To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal symptoms in adults with constipation.
Constipation is a commonly diagnosed gastrointestinal disorder with an estimated prevalence in the general population of 12-19%, which results in lower quality of life and significant healthcare costs to the individual. Almost 9 in 10 physician visits for constipation result in a laxative prescription. Additionally, consumers in the USA and in the United Kingdom spend almost 1 billion dollars annually for over-the-counter laxatives. Chronic constipation is diagnosed almost solely on patient symptoms, which generally includes unsatisfactory defecation due to infrequent stools, difficult stool passage, or both. The cause of chronic constipation is unknown and likely multifactorial with physiological changes, psychological factors, and lifestyle influences identified as possible culprits. Consequently, identification of effective constipation treatments remains a challenge. The initial management of constipation symptoms is focused on evaluating lifestyle and diet variables as possible culprits. If lifestyle modifications are unsuccessful in alleviating constipation, various medications may be prescribed. In fact, about 50% of adults with constipation are not completely satisfied with available treatments. Consequently, there is a clear need for alternative constipation treatments that are safe, effective, and cost-effective. Probiotics are live micro-organisms that result in a health benefit for the host when administered in adequate dosages. In recent years, probiotics have been commonly used to alleviate symptoms in a variety of gastrointestinal disorders. It is hypothesized that probiotics help to maintain gut lumen homeostasis by hindering growth of luminal pathogens and restoring the normal flora of the gut. As such, the use of probiotics for the relief of constipation symptoms is very promising. Numerous studies have been published addressing the utility of probiotics for gastrointestinal health including constipation. However, since probiotic efficacy is largely strain-specific, each specific strain must be individually tested in clinical trials. Given the promising clinical results of probiotics on gastrointestinal health to date, the objective of this clinical trial is to evaluate the safety and effectiveness of 4-week Bifidobacterium lactis HN019 supplementation, in a dose-ranging fashion, on Colonic Transit Time (CTT) and gastrointestinal symptoms in adults with constipation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
228
Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks.
Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks. One capsule of study product, mixed with provided yogurt, will be consumed once a day.
EUROFINS OPTIMED Clinical Research
Gières, France
Colonic transit time
Time frame: The primary outcome of Colonic Transit Time will be evaluated with abdominal x-rays on days 0 and 28
Patient (syn. participant) assessment of constipation symptoms (PAC-SYM)
Time frame: At days 0 and 28
Patient Assessment of Constipation Quality of Life (PAC-QoL)
Time frame: At days 0 and 28
Bowel Function Index
Time frame: At days 0 and 28
Adequate Relief of constipation (yes/no)
Time frame: At days 0 and 28
Bowel movement frequency stools per week)
Time frame: Participants will record the number of defecations per day in a daily diary during the 2-week run-in period and each day during the 4-week supplementation period
Stool consistency (Bristol Stool Scale)
Time frame: Participants will record stool consistency during the 2-week run-in period and each day during the 4-week supplementation period.
Degree of Straining (1-5 scale)
Time frame: Participants will record degree of straining during the 2-week run-in period and each day during the 4-week supplementation period.
Participant assessment of bowel emptying (yes/no)
Time frame: Participants will record sensation of complete bowel emptying during the 2-week run-in period and each day during the 4-week supplementation period.
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Participants will consume placebo capsules only during the 2-week run-in period. After randomization, participants will be administered their assigned study product and will continue on the product for 4 weeks.
Abdominal discomfort/bloating (1-5 scale)
Time frame: Participants will record severity of abdominal discomfort and bloating during the 2-week run-in period and each day during the 4-week supplementation period.
Overall product satisfaction (1-5 scale)
Time frame: At the end of the supplementation period (D28)